TMC435-TiDP16-C119 - A Study Comparing 2 New Capsule Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Respective Blood Levels of TMC435 Following Single Dose Administration

Sponsor

Tibotec Pharmaceuticals, Ireland (Industry)

Overall Status

Completed

CT.gov ID

NCT01134718

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to compare in healthy volunteers levels of TMC435 in the blood circulation after intake of 2 new capsule formulations with the level of TMC435 in the blood circulation after intake of the capsule formulation used in the Phase IIb studies.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Virus	Drug: TMC435 (G006) Drug: TMC435 (F021) Drug: TMC435 (G007)	Phase 1

Detailed Description

This is a randomized (study drug assigned by chance), open-label (all people involved know the treatment), single dose, crossover (volunteers will receive different treatments sequentially during the trial) study in healthy volunteers. The trial will evaluate the levels of TMC435 in the blood circulation after a single dose of 150 mg TMC435 administered as 3 different capsule formulations following breakfast. There will be a 7-day washout period between treatments and a 4-5 week follow-up at the end. Each volunteer will receive all three treatments. The main focus of the trial is the pharmacokinetic characteristics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of the different formulations. This evaluation requires multiple blood samples from Day 1 through 72 hours after dosing. Safety assessments (lab work, blood pressure, pulse and electrocardiogram) will follow a different schedule and are measured on Day -1 (day prior to taking first dose of drug), Day 1 (without lab work) and Day 4 of each treatment period, and 1 and 4-5 weeks after the last treatment. Each volunteer will receive 3 treatments, 7 days apart from each other. Each treatment consists of one single oral dose of 150 mg TMC435.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pilot BA Study With Phase III/Commercial Versus Phase IIB Formulation. A Phase I, Open Label, Randomized, Single Dose, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of TMC435 Following Administration of Potential Phase III Formulations Compared to the Phase IIb Capsule

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 001 TMC435 (F021) one morning dose of 150 mg	Drug: TMC435 (F021) one morning dose of 150 mg
Experimental: 002 TMC435 (G006) one morning dose of 150 mg	Drug: TMC435 (G006) one morning dose of 150 mg
Experimental: 003 TMC435 (G007) one morning dose of 150 mg	Drug: TMC435 (G007) one morning dose of 150 mg

Arm

Intervention/Treatment

Experimental: 001

TMC435 (F021) one morning dose of 150 mg

Drug: TMC435 (F021)

one morning dose of 150 mg

Experimental: 002

TMC435 (G006) one morning dose of 150 mg

Drug: TMC435 (G006)

one morning dose of 150 mg

Experimental: 003

TMC435 (G007) one morning dose of 150 mg

Drug: TMC435 (G007)

one morning dose of 150 mg

Outcome Measures

Primary Outcome Measures

Rate and extent of absorption of TMC435 following administration of 3 different capsule formulations under fed condition [Measured over a period of 4 consecutive days (Day1-Day4) per treatment. Treatments (3) are 7 days apart from each other. During 1st day of each treatment, 10 blood samples for determination of pharmacokinetic characteristics are taken.]

Secondary Outcome Measures

All reported Adverse Events + percentage of subjects who experienced at least 1 occurrence of a given event as a measure of Safety and Tolerability following administration of single doses of 150 mg TMC435 [Till last follow up safety visit 4-5 weeks after last intake of study medication]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Non-smoker for at least 3 months
Body Mass Index of 18.0 to 30.0 kg/m2
Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram

Exclusion Criteria:

Infection with Hepatitis A, B or C virus
Infection with the human immunodeficiency virus (HIV)
History of, or any current medical condition which could impact the safety of the participant in the study